Product Information for Complex Hernia Repair

Collagen Matrix for Soft Tissue Reconstruction

Value Analysis Committee

Product Information for Complex Hernia Repair

WHY INTEGRA IS DEDICATED TO L I M I T I N G U N C E RTA I N T Y FOR THE BUSIEST SURGEONS.

Surgeons don’t have a minute to waste. They navigate a world of uncertainty while making thousands of decisions every day. These decisions directly affect patients - and surgeons. Integra knows this. By limiting uncertainty, we promise to do our part so that busy surgeons can continue to make the right decisions with confidence, and focus on what is most important.

Making everything you touch and do as simple as possible.

Simplifying procedures and products to eliminate unnecessary steps, recognizing that time is your scarcest resource.

Involving surgeons in creating be� er products and procedures because we believe surgery is a blend of art and science.

Having the best trained professionals dedicated to anticipating the needs of the busiest surgeons.

Delivering our products when and where you need them, every time.

Quickly replacing or repairing products, because minutes ma� er.

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Integra Brand PromisesIntegra Promises to Limit Uncertainty by:

INTEGRA LIFESCIENCES OVERVIEW

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in reconstructive and general surgery, orthopedic extremity surgery, and neurosurgery.

TABLE OF CONTENTS

Product Introduction ..............................................................................................................................4Hernia Mesh Selection Criteria .....................................................................................................................................5Product Technology & Differentiation ....................................................................................................................... 6510(k) Clearance ..............................................................................................................................................................8Instructions for Use ......................................................................................................................................................10

Economic-Value Proposition ................................................................................................................ 12Value Analysis ................................................................................................................................................................ 12Clinical Review ............................................................................................................................................................... 14

Competitive Information ...................................................................................................................... 15Competitive Overview ................................................................................................................................................. 15

Reimbursement ..................................................................................................................................... 16

Material Management Information ..................................................................................................... 19Product Order Codes .................................................................................................................................................... 19

Value-Added Programs ......................................................................................................................... 21Clinical Training ............................................................................................................................................................. 21Reimbursement Hotline ............................................................................................................................................... 21

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COMPLEX HERNIA REPAIR

HERNIA MESH SELECTION CRITERIA

^The modified VHWG classification system was developed (2012) to accurately predict surgical site occurrence (SSO) after open ventral hernia repair. SSO was defined as development of an infection, seroma, wound dehiscence, or formation of an enterocutaneous fistula.

1. Breuing K, Butler CE, Ferzoco S, et al. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery 2010;148:544e558. 2. Kanters AE, Krpata DM, Blatnik JA, Novitsky YM, Rosen MJ (2012) Modified hernia grading scale to stratify surgical site occurrence after open ventral hernia repairs. Journal of the American College of Surgeons 215 (6): 787-793.

MESHTYPE

Permanent Synthetic

Resorbable Synthetic (Biosynthetic)

Biologic

VENTRAL HERNIA WORKING GROUP (VHWG)1

CLASSIFICATION

Grade 1Choice of repair material by surgeon and patient factors

Grade 2Increased risk of SSO suggest

additive risk for permanent synthetic repair material and

potential advantage for appropriate biologic reinforcement

Grade 3Permanent synthetic material generally not recommended;

potential advantage to non-permanent material

Grade 4Permanent synthetic material generally not recommended &

non-permanent material should be considered

RISK LEVEL & CHARACTERISTICS

LOW RISK• Low risk for complications

• No history of wound infection

CO-MORBID• Smoker • Obese• Diabetic • Immunosuppressed• COPD

HIGH RISK• Previous wound infection

• Stoma present• Violation of the gastrointestinal tract

HIGHEST RISK• Following removal of infected mesh

• Septic dehiscence

MODIFIED VHWG^2

CLASSIFICATION & RISK

Grade 1LOW RISK

Grade 2CO-MORBID

Grade 3HIGH RISK

CHARACTERISTICS & SSO INCIDENCE

• Low risk for complications• No history of wound infection

SSO = 14%

• Smoker • Obese• Diabetic

• History of wound infection• COPD

SSO = 27%

A. Clean-ContaminatedB. Contaminated

C. Dirty

SSO = 46%

Repair technique and reinforcing material selection are among many considerations surgeons have prior to performing a ventral hernia repair. Many surgeons consider the Ventral Hernia Working Group (VHWG) grading system or its modified version to assess the risk of surgical site complications in patients undergoing ventral hernia repair. This grading scale also helps surgeons decide what type of reinforcing matrix to use for their hernia repairs, relative to each patient.

As the manufacturer of this device, Integra does not practice medicine and does not make specific recommendations for patients. The surgeon performing the procedure is responsible for determining and using the appropriate product for each patient.

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SURGIMEND FOR HERNIA REPAIR

Complex abdominal wall repairs (CAWR) can be difficult and costly to repair. Patients often suffer from complications such as hernia recurrence, infection at the site of repair, or within the wound itself. Surgeons seek hernia repair matrices that demonstrate low recurrence rates and the ability to provide a durable, long-lasting repair for their patient. SurgiMend addresses these concerns.

Strattice™

Reconstructive Tissue Matrix

30 months

SurgiMend® Collagen Matrix for Soft Tissue Reconstruction

26 months

Low RecurrenceEffective reinforcement over time

Clinical evidence demonstrates SurgiMend® reinforcement resulted in low

12 articles published in peer-reviewed journals since 2012.1-12

years post-implantation.*recurrence rates for complex abdominal wall repair patients, followed4%-8% 5-UP TO-

As highlighted in radiographic images from clinical cases, SurgiMend persisted to effectively reinforce, whereas Strattice™ was more difficult to distinguish >2 years post-op.16

Low Recurrence Material Matters Rapid Revascularization

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In complex hernia repair, surgeons have a variety of source material to choose from however, not all biologic matrices are created equal. SurgiMend is the only bovine-dermal matrix, offering stronger and thicker configurations when compared to Strattice.

For a long-lasting repair, surgeons require biologic matrices that allow for rapid revascularization and integration with the patient’s own tissue.

Rapid RevascularizationIntegration and tissue building

SurgiMend 3.0SurgiMend MP

4 weeks post-implantation†

SurgiMend rapidly revascularizes to support tissue building for prolonged reinforcement.14, 15†

SurgiMend integrates with host’s own tissue for a lasting repair.14†

Materials MattersA unique bovine dermal matrix

SurgiMend is stronger compared with Strattice, due to structural differences.17

Tear

Randomized orientation of bovine fibers translates to

strength and tear resistance17

SurgiMend

Porcine collagen fibers are uniformly oriented17

Strattice

TearPublished bench testing results show SurgiMend 3.0 & 4.0 demonstrate13:

than Strattice™.

-AND-more tear resistance

higher tensile & suture retention strength4× >2×

* Based on data from: Giordano SA, et al. [N=223; RR=6.2%, excluding bridging; AFU=30.5; ADMP=underlay with ACS]; Garvey PB, et al. [N=60; RR=6.4% (3 yr) & 8.3% (5 yr), excluding bridging; AFU=52.9; ADMP=underlay with ACS]; Soares KC, et al. [N=67; RR=3.5%; AFU=8.7; ADMP=sandwich technique or onlay]; Garvey PB, et al. [N=135; RR=6.4%, excluding bridging; AFU=28.1; ADMP=underlay with ACS]; Clemens M, et al. [N=51; RR=3.9%; AFU=18.1; ADMP=underlay with ACS]; Lineaweaver W, et al. [N=15; RR=7.0%, excluding bridging; AFU=18.0; ADMP=onlay with ACS].1-6

† Preclinical data. Results may not correlate to clinical performance.1. Giordano, S., Garvey, P. B., Baumann, D. P., Liu, J., & Butler, C. E. (2017). Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis. Surgery (United States), 161(2), 499–508. 2. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2016;224(3):341-350. 3. Soares KC, Baltodano PA, Hicks CW, et al. Novel wound management system reduces surgical site morbidity after ventral hernia repairs: a critical analysis. Am J Surg. 2015;209(2):324-332. 4. Garvey PB, Martinez RA, Baumann DP, et al. Outcomes of abdominal wall reconstruction with acellular dermal matrix are not affected by wound contamination. J Am Coll Surg. 2014;219(5):853-864. 5. Clemens M, Selber J, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast Reconstr Surg. 2013;131(1):71-79. 6. Lineaweaver W. Improvement of success rates for abdominal component reconstructions using bovine fetal collagen. Ann Plast Surg. 2012;68(5):438–441. 7. Giordano SA, Garvey PB, Baumann DP, Liu J, Butler CE. Hospital readmission following open, single-stage, elective abdominal wall reconstructions using acellular dermal matrix affects long-term hernia recurrence rate. Am J Surg. 2018;216(1):60-66. 8. Booth JH, Garvey PB, Baumann DP, et al. Primary Fascial Closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):999-1009. 9. Azar FK, Crawford TC, Poruk KE, et al. Ventral hernia repair in patients with abdominal loss of domain: an observational study of one institution’s experience. Hernia. 2017;21(2):245-252. 10. Hicks CW, Poruk KE, Baltodano PA, et al. Long-term outcomes of sandwich ventral hernia repair paired with hybrid vacuum-assisted closure. J Surg Res. 2016;204(2):282-287. 11. Janfaza M, Martin M, Skinner R. A preliminary comparison study of two noncrosslinked biologic meshes used in complex ventral hernia repairs. World J Surg. 2012;36(8):1760-1764. 12. Giordano S, Garvey PB, Baumann DP, Liu J, Butler CE. Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis. Surg. 2017;161(2):499-508. 13. Adelman DM, Selber JC, Butler CE. Bovine versus porcine acellular dermal matrix: a comparison of mechanical properties. Plast Reconstr Surg Glob Open. 2014;2(5):e155. 14. Adelman, D. M., & Cornwell, K. G. (2018). Bioprosthetic Versus Synthetic Mesh: Analysis of Tissue Adherence and Revascularization in an Experimental Animal Model. Plastic and Reconstructive Surgery. Global Open, 6(5), e1713. 15. Cornwell KG, Zhang F, Lineaweaver W. Bovine fetal collagen reinforcement in a small animal model of hernia with component repair. J Surg Res. 2016;201(2):416-424. 16. Adelman DM. Radiographic evaluation of biologic mesh repair in ventral abdominal herniorrhaphy. Presented at the American College of Surgeons (ACS) Annual Clinical Congress. Washington DC; 2013. 17. Wells HC, Sizeland KH, Kirby N, Hawley A, Mudie S, Haverkamp RG. Collagen fibril structure and strength in acellular dermal matrix materials of bovine, porcine, and human origin. ACS Biomater Sci Eng. 2015;1(10):1026-1038.

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SurgiMend® Collagen Matrix For Soft Tissue Reconstruction

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SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

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INSTRUCTIONS FOR USE

DescriptionSurgiMend® is an acellular dermal tissue derived from bovine dermis. The device is available in solid, fenestrated, and perforated configurations. The device is supplied sterile in a variety of sizes, shapes, and thicknesses.

IndicationsSurgiMend® is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.SurgiMend® is specifically indicated for:

• Plastic and reconstructive surgery• Muscle flap reinforcement• Hernia repair including abdominal, inguinal,

femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Contraindications• SurgiMend® should not be used for patients

with a known history of hypersensitivity to collagen or bovine products.

Warnings and PrecautionsCAUTION: Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner.

• Fluid flows through the fenestrated and perforated product faster than through solid product.

• Fenestrated product will stretch more than non-fenestrated product.

• Meshing of fenestrated or perforated product is not recommended.

• Do not expose to chemicals or substances other than sterile, room temperature 0.9% saline.

• Excessive heat can damage collagen. Do not hydrate in 0.9% saline warmed above room temperature. If, when hydrated, the product shrinks in size, DO NOT use the product as it may be damaged.

SurgiMend®

Collagen Matrix for Soft Tissue Reconstruction

• SurgiMend® should be used with caution in regions where infection exists or is suspected. Treat any existing infection appropriately. If used in contaminated or infected wounds, collagen-based implants can weaken or break down.

• SurgiMend® should be used with caution in surgical locations where the product may be exposed to stomach and/or intestinal contents. Collagen-based implants can be susceptible to degradation by digestive enzymes and conditions of acidic (low) pH.

• SurgiMend® is for single patient use only; do not resterilize as this may damage SurgiMend®.

• SurgiMend® has not been evaluated for use in pregnant women.

• The patient’s medical condition may adversely impact healing of the deficient tissue. These conditions may include, but are not limited to: smoking, diabetes, insufficient blood supply at the implant site, and exposure of the implant site to radiotherapy.

• Do not use product past the date of expiration.

• Do not use the device if the foil seal is broken.• Discard all opened and unused portion(s) of

the device.

Potential Complications

General risks may include, but are not limited

to: infection, allergic reactions, pain, swelling or

bruising, foreign body reactions, acute or chronic

inflammatory reactions, adhesions, seromas,

hematomas, and repair laxity. The patient should

be made aware of these risks and others associated

with general surgery and the use of anesthesia.

Instructions for Use

Note:

• Consider the strength requirement when

selecting the product thickness; non-

fenestrated, non-perforated, and thicker

products will have greater initial strength.

Application

• Inspect packaging, and if the foil pouch is

damaged or opened then discard the device.

• If necessary, rinse surgical gloves to remove

any glove powder prior to touching product.

• Peel open the outer foil package and

aseptically deliver inner, sterile package to

sterile field.

• Remove the product from package using

sterile, atraumatic forceps or gloved hand.

• Submerge the device in sterile, room

temperature 0.9% saline to ensure that it

is completely hydrated (typically about 1-3

minutes; thicker devices may take longer than

thinner devices). Hydration is indicated by a

color change from white (dry) to gray (wet).

• To facilitate hydration, pressure can be applied

with gloved fingers across the surface of the

device until SurgiMend® has a uniform gray,

wet appearance.

• While dry, or following soaking in sterile,

room temperature, 0.9% saline, cut the

device to the size and shape needed.

• Keep the device immersed in sterile, room

temperature, 0.9% saline until ready for use

• For best results, the device should be applied

and fixed in place carefully.

• Adequate overlap of SurgiMend® with healthy

host tissue is recommended.

• SurgiMend® should be fixed in place using

standard suturing techniques encompassing

both graft and host tissue.

• Discard any unused pieces of the device.

Safety

SurgiMend® is manufactured from bovine skin. The

source material is processed and solely derived

from cattle in compliance with United States and

European regulatory requirements.

Storage

• Store at room temperature: 15 - 30°C (59 -

86°F).

• Keep away from excessive heat and direct

sunlight.

How Supplied

• SurgiMend® is supplied sterile in single use,

double-peel packages in a variety of sizes.

• As long as the package has not been damaged

or opened, the contents are guaranteed

sterile.

• SurgiMend® is offered in solid and fenestrated

configurations.

• SurgiMend® MP is offered in a perforated

configuration (2-3 mm diameter holes).

• Availability of each product model or

catalogue number may differ in each country.

Please consult Integra Customer Service or

local Integra representative for further details.

Please see packaging for full instructions for use.

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The Ventral Hernia Working Group does not recommend the use of synthetic mesh in Grade 3 or Grade 4 hernias.1 Study data has shown that complications occur more frequently in patients treated with synthetic mesh, with a readmission rate three times that of biologic mesh.2

VALUE ANALYSIS

A study published by Otake et al. 2013 indicates that biologic mesh does not result in a significant direct-cost burden to the institution, and may lower longer-term costs associated with complications, as compared to synthetic meshes.3

a

b

Compared to biologic mesh, the costs of complications for patients requiring explantation of synthetic mesh is:

Complication Rates from Grade 3 Patients - DeNoto et al.2

Synthetic Mesh (n=268) Primary Repair (n=214)Xenograft (n=56)

b

40%

30%

35%

25%

20%

15%

10%

5%

0%

Infected Mesh Removal

Infection SeromaHernia Reccurance Other ComplicationGra�/Mesh/WoundComplication

Overall Rate of Complication

Bowel Obstruction/Other

Gastrointestinal Complication

40%

30%

35%

25%

20%

15%

10%

5%

0%

Infected Mesh Removal

Infection SeromaHernia Reccurance Other ComplicationGra�/Mesh/WoundComplication

Overall Rate of Complication

Bowel Obstruction/Other

Gastrointestinal Complication

-VS-for synthetic mesh

$7,528for biologic mesh

$74410x higher for infected mesh removal2

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SurgiMend provides a durable, long-lasting repair and reduces the likelihood of hernia recurrence, costly readmissions, and financial burden to the healthcare system:

SURGIMEND RECURRENCE RATES

1. Breuing K. et al. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010. 2. DeNoto G III, Nancy Reaven, Susan Funk, Ventral hernia: retrospective cost analysis of primary repair, repair with synthetic mesh, and repair with acellular xenograft implant. Open Access Surgery. 2013. 3. Otake, L. R., Satterwhite, T., Echo, A., Chiou, G. & Lee, G. K. Single-Institution Financial Analysis of Biologic Versus Synthetic Mesh Hernia Repair: A Retrospective Analysis of Patients Readmitted for Hernia Repair. Annals of Plastic Surgery. 2013. 4. Fischer, J.P., Basta, M.N., Mirzabeigi, M.N. et al. A comparison of outcomes and cost in VHWG grade II hernias between Rives-Stoppa synthetic mesh hernia repair versus underlay biologic mesh repair. Hernia. 2014. 5. Gossetti, F., D’Amore, L., Ceci, F. et al. Abdominal wall reconstruction (AWR): the need to identify the hospital units and referral centers entitled to perform it. Updates in Surgery. 2017.

Clinical evidence demonstrates SurgiMend reinforcement resulted in a low 4 – 8% recurrence rate in CAWR patients followed up to 5 years post-implantation.

In the US, ventral hernia repairs are estimated to cost at least $3.2B annually. Any reductions in recurrence rates may result in substantial cost savings. Every 1% reduction in procedural rates could result in a savings of approximately $32 million annually.5

The hospital costs for a readmission related to a CAWR are significantly higher than those for the index admission ($29,809 for the index admission, vs. $57,267 for readmission) according to a US-based, single site study reviewing 72 patients.4 The resulting reimbursement for the readmission would likely be the same as the index admission.

Study n=patients Recurrence RateAverage Follow-Up

(months)Biologic Graft Placement

Giordano (2017) 223 6.2%* 30.5 Underlay with ACS

Garvey (2016) 60 6.4% (3 yr)* 8.3% (5 yr)* 52.9 Underlay with ACS

Soares (2014) 67 3.5% 8.7 Sandwich Technique or Onlay

Garvey (2014) 135 6.4%* 28.1 Underlay with ACS

Clemens (2013) 51 3.9% 18.1 Underlay with ACS

Lineaweaver (2012) 15 7.0* 18.0 Underlay with ACS

*excludes bridging

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CLINICAL REVIEW

SUMMARY OF SELECTED PUBLISHED CLINICAL DATA ON SURGIMEND FOR ABDOMINAL WALL REPAIR

TITLE AUTHOR(S) YEAR OF PUB.REPAIR

TECHNIQUE

VHWG GRADE/

MODIFIED VHWG GRADE

HERNIA RECURRENCE RATE

FOLLOW-UP # PATIENTS# SURGIMEND

PATIENTSOTHER ADMs

USED

Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis

Giordano S, et al.1 2017

underlay with ACS

II, III, IV /2, 3

6.2% excluding bridged repairs

30.5 +/- 22.3 months

535 223Strattice™, AlloDerm™

Long-Term Outcomes after Abdominal Wall Reconstruction with Acellular Dermal Matrix

Garvey PB, et al.2 2016

underlay with ACS

I, II, III, IV / 1, 2, 3

6.4% at 3 years, and 8.3% at 5

years (excluding bridged and

human ADM)

52.9 (range 36-104)

191 60Strattice™, AlloDerm™

Novel wound management system reduces surgical site morbidity after ventral hernia repairs: a critical analysis

Soares KC, et al.3 2014

sandwich technique

I, II, III, IV / 1, 2, 3

3.5% overall8.7 +/- 9.9

months199 67 None

Outcomes of Abdominal Wall Reconstruction with Acellular Dermal Matrix Are Not Affected by Wound Contamination

Garvey PB, et al.4 2014

underlay with ACS

I, II, III, IV / 1, 2, 3

6.2-6.5% excluding

bridged repairs28.1 +/- 19.1 359 135

Strattice™, AlloDerm™

Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction

Clemens MW, et al.5 2013

underlay with ACS

II, III, IV / 2, 3

3.90% 21 months 120 51 Strattice™

Improvement of success rates for abdominal component reconstructions using bovine fetal collagen

Lineaweaver W6 2012 ACSNot

specified7% 18 months 15 15 none

1. Giordano, S., Garvey, P. B., Baumann, D. P., Liu, J., & Butler, C. E. (2017). Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis. Surgery (United States), 161(2), 499–508. 2. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2016;224(3):341-350. 3. Soares KC, Baltodano PA, Hicks CW, et al. Novel wound management system reduces surgical site morbidity after ventral hernia repairs: a critical analysis. Am J Surg. 015;209(2):324-332. 4. Garvey PB, Martinez RA, Baumann DP, et al. Outcomes of abdominal wall reconstruction with acellular dermal matrix are not affected by wound contamination. J Am Coll Surg. 2014;219(5):853-864. 5. Clemens M, Selber J, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast Reconstr Surg. 2013;131(1):71-79. 6. Lineaweaver W. Improvement of success rates for abdominal component reconstructions using bovine fetal collagen. Ann Plast Surg. 2012;68(5):438–441.

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Clinical evidence demonstrates SurgiMend reinforcement resulted in a low 4 – 8% recurrence rate in CAWR patients followed up to 5 years post-implantation.

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COMPETITIVE OVERVIEW

SURGIMEND VS OTHER BIOLOGICS

SURGIMEND VS RESORBABLE SYNTHETICS

Product Company Source Sizes Thicknesses* Perforated

SurgiMend®

Integra LifeSciences

Bovine dermis

Smallest: 3cm x 3cmLargest: 25cm x 40cm 1mm, 2mm, 3mm & 4mm

SurgiMend® MPSmallest: 10cm x 15cmLargest: 25cm x 40cm 2mm

Strattice™

AllerganPorcine dermis

Smallest: 6cm x 6cmLargest: 25cm x 40cm

1.7mm

Strattice™ PerforatedSmallest: 10cm x 16cm Largest: 25cm x 40cm

1.7mm

Strattice™ Xtra ThickSmallest: 10cm x 16cm Largest: 25cm x 40cm

2.5mm

XenMatrix™

BD/BardPorcine dermis

Smallest: 6cm x 6cm Largest: 30cm x 45cm

2mm

XenMatrix™ ABSmallest: 6cm x 6cm Largest: 19cm x 35cm

Product Company Source Sizes Thicknesses* Perforated

SurgiMend® MPIntegra®

LifeSciencesBovine dermis

Smallest: 10cm x 15cmLargest: 25cm x 40cm 2mm

Phasix™ BD/Bard

P4HB-Resorbable Synthetic

Smallest: 7.6cm Circle Largest: 50cm x 50cm

Not Reported N/A

Gore Bio-A® Gore MedicalPGA/Trimethylene carbonate-

Resorbable Synthetic

Smallest: 7cm x 10cmLargest: 20cm x 30cm

Not Reported N/A

*Nominal Thickness Full cross-reference file available upon request.

*Nominal Thickness Full cross-reference file available upon request. Competitor promotional material on file.

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INPATIENT ICD -9- CM MAPPING TO ICD -10 PC S PROCEDURES INVOLVING THE USE OF SURGIMEND® IN HERNIA REPAIR (2018/2019)

Effective October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) implemented International Classification of Diseases, 10th Revision (ICD-10) Procedure Coding System (PCS) in place of the 9th Revision (ICD-9) procedure codes. CMS has provided a General Equivalence Mappings (GEMS) that crosswalk ICD-9 procedure codes to ICD-10 PCS (available at https://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS- and-GEMs.html). Below, Integra LifeSciences Corporation provides the mappings for select ICD-9 procedure codes. While Integra LifeSciences Corporation intends to use reasonable efforts to provide accurate coding information, this information should not be construed as providing clinical advice, dictating reimbursement policy, or substituting for the judgment of a practitioner. It is always the Provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Integra LifeSciences Corporation assumes no responsibilities or liabilities for the timeliness, accuracy, and completeness of the information contained herein. Since reimbursement laws, regulations, and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists, and/or legal counsel regarding coverage, coding and payment issues.

MS-DRG MS-DRG DescriptionMedicare National Average Payment*

163 Major Chest Procedures with MCC $30,053.18

164 Major Chest Procedures with CC $15,694.03

165 Major Chest Procedures without CC/MCC $11,316.76

326 Stomach, Esophageal and Duodenal Procedures with MCC $32,109.55

327 Stomach, Esophageal and Duodenal Procedures with CC $15,177.18

328 Stomach, Esophageal and Duodenal Procedures without CC/MCC $9,421.06

350 Inguinal and Femoral Hernia Procedures with MCC $14,946.26

351 Inguinal and Femoral Hernia Procedures with CC $9,164.47

352 Inguinal and Femoral Hernia Procedures without CC/MCC $6,436.08

353 Hernia Procedures Except Inguinal and Femoral with MCC $18,119.39

354 Hernia Procedures Except Inguinal and Femoral with CC $10,575.09

355 Hernia Procedures Except Inguinal and Femoral without CC/MCC $8,276.80

907 Other O.R. Procedures for Injuries with MCC $25,757.17

908 Other O.R. Procedures for Injuries with CC $12,174.49

909 Other O.R. Procedures for Injuries without CC/MCC $8,097.19

957 Other O.R. Procedures for Multiple Significant Trauma with MCC $46,421.06

958 Other O.R. Procedures for Multiple Significant Trauma with CC $25,535.40

959 Other O.R. Procedures for Multiple Significant Trauma without MCC $14,971.91

Reference: The ICD-10-PCS codes and descriptors, and DRG payment groups are effective October 1, 2018.

For assistance with coding and reimbursement, please contact our Integra Reimbursement Hotline at 1-877-444-1122, option 3, option 1, Monday to Friday, 8 am to 6 pm, or via email at [email protected]

Integra has online reimbursement resource for SurgiMend in hernia and abdominal wall repair. You can find the most up-to-date codes and reimbursement rates at https://www.surgimend.com/resources/reimbursement-information/

*The Medicare average payment rates provided are a benchmark reference only. There is no official publication of the average hospital rate; therefore, the national average payments provided in the table above are approximate.

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INGUINAL Hernia Repair

ICD-9 Procedure Code

ICD-10 PCS Root Operation

Code DescriptionPotential MS-DRG

Assignment

17.11

OYU –Supplement, Inguinal Region

Laparoscopic repair of direct inguinal hernia with graft or prosthesis

350-355

17.12 Laparoscopic repair of indirect inguinal hernia with graft or prosthesis

17.13 Laparoscopic repair of inguinal hernia with graft or prosthesis, not otherwise specified

17.21 Laparoscopic bilateral repair of direct inguinal hernia with graft or prosthesis

17.22 Laparoscopic bilateral repair of indirect inguinal hernia with graft or prosthesis

17.23 Laparoscopic bilateral repair of inguinal hernia, one direct and one indirect, with graft or prosthesis

17.24 Laparoscopic bilateral repair of inguinal hernia with graft or prosthesis, not otherwise specified

53.03 Other and open repair of direct inguinal hernia with graft or prosthesis

53.04 Other and open repair of indirect inguinal hernia with graft or prosthesis

53.05 Unilateral repair of inguinal hernia with graft or prosthesis, not otherwise specified

53.14 Other and open bilateral repair of direct inguinal hernia with graft or prosthesis

53.15 Other and open bilateral repair of indirect inguinal hernia with graft or prosthesis

53.16 Other and open bilateral repair of inguinal hernia, one direct and one indirect, with graft or prosthesis

53.17 Bilateral inguinal hernia repair with graft or prosthesis, not otherwise specified

DIAPHRAGMATIC Hernia Repair

ICD-9 Procedure Code

ICD-10 PCS Root Operation

Code DescriptionPotential MS-DRG

Assignment

53.71 0BU –Supplement/Respiratory System

Laparoscopic repair of diaphragmatic hernia, abdominal approach 163-165,326-328,907-909,957-959

53.72 Other and open repair of diaphragmatic hernia, abdominal approach

53.75 Repair of diaphragmatic hernia, abdominal approach, not otherwise specified

FEMORAL Hernia Repair

ICD-9 Procedure Code

ICD-10 PCS Root Operation

Code DescriptionPotential MS-DRG

Assignment

53.21 OYU –Supplement, Femoral Region

Unilateral repair of femoral hernia with graft or prosthesis350-355

53.31 Bilateral repair of femoral hernia with graft or prosthesis

UMBILICAL Hernia Repair

ICD-9 Procedure Code

ICD-10 PCS Root Operation

Code DescriptionPotential MS-DRG

Assignment

53.41 OWU -Supplement,Abdominal Wall

Other and open repair of umbilical hernia with graft or prosthesis 350-355907-909,957-95953.42 Laparoscopic repair of umbilical hernia with graft or prosthesis

VENTRAL Hernia Repair

ICD-9 Procedure Code

ICD-10 PCS Root Operation

Code DescriptionPotential MS-DRG

Assignment

53.61

OWU -Supplement, Abdominal Wall

Other open incisional ventral hernia repair with graft or prosthesis

350-355,907-909,957-959

53.62 Laparascopic incisional ventral hernia repair with graft or prosthesis

53.63 Other laparoscopic repair of other hernia of anterior abdominal wall with graft or prosthesis

53.69 Other and open repair of other hernia of anterior abdominal wall with graft or prosthesis

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REIMBURSEMENT INFORMATION

It is estimated that close to 300,000 abdominal hernia repair procedures, using mesh reinforcement,

were performed in 2016.1 The payer mix for the patients treated with these procedures is primarily Medicare and Private Insurance.2

The majority of patients receiving mesh-reinforced abdominal wall repair procedures are

between the ages of 45 and 84, with nearly half of the procedures occurring in patients between the ages of 45 and 64.2

Medicare 45.98%

Private Insurance

35.45%

Medicaid 12.59%

Other 2.87%

Uninsured 2.89%

Payer Category / Percent of Discharges

45-64 y/o47.11%

65-84 y/o35.35%

18-44 y/o14.54%

1-17 y/o 0.12%

85+ y/o2.86%

Age Group / Percent of Discharges

1. Data provided by TforG - an IQVIA company, on file with Integra LifeSciences. 2. HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD.

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Only SurgiMend® is offered in a wide variety of thicknesses up to 4 mm (including a macroporous, 2 mm thickness: SurgiMend MP)

* Nominal Thickness (p) Perforated (f) Fenestrated

Ordering Information

Shape Description cm2 SurgiMend Thin0.6 mm*

SurgiMend 1.01 mm*

SurgiMend 2.02 mm*

SurgiMend MP2 mm*

SurgiMend 3.03 mm*

SurgiMend 4.04 mm*

Strip

0.3 cm x 25 cm 7.5 - 606-003-001 - - - -

0.5 cm x 20 cm 10 - - - - - 606-403-001

0.6 cm x 25 cm 15 - 606-003-002 - - - -

1.0 cm x 25 cm 25 - 606-003-003 - - - -

3 cm x 3 cm 9 606-002-005 606-001-012 - - - -

Rectangle / Square

4 cm x 7 cm 28 606-002-002 606-001-013 - - - -

4 cm x 12 cm 48 - 606-001-014 - - - -

4 cm x 16 cm 64 - 606-001-010 - - - -

5 cm x 6 cm 30 606-002-003 606-001-002 606-200-002 - 606-300-002 606-400-002

6 cm x 12 cm 72 - 606-001-004 606-200-004 - 606-300-004 606-400-004

6 cm x 16 cm 96 - 606-001-015 - - - -

8 cm x 12 cm 96 606-005-003 - - - - -

8 cm x 16 cm 128 - 606-001-018 - - - -

10 cm x 10 cm 100 - 606-001-005 - - - -

10 cm x 15 cm 150 606-005-004 606-001-006 606-200-006 606-206-001 (p) 606-300-006 606-400-006

10 cm x 20 cm 200 - 606-001-007 - - - -

13 cm x 25 cm 325 - 606-001-009 606-200-009 606-206-003 (p) 606-300-009 606-400-009

16 cm x 20 cm 320 - 606-001-008 606-200-008 606-206-004 (p) 606-300-008 -

20 cm x 20cm 400 - - 606-200-019 606-206-002 (p) 606-300-019 -

20 cm x 25 cm 500 - - 606-200-020 606-206-005 (p) 606-300-020 -

20 cm x 30 cm 600 - 606-001-017 606-200-017 606-206-006 (p) 606-300-017 606-400-017

25 cm x 40 cm 1,000 - 606-001-016 606-200-016 606-206-007 (p) 606-300-016 606-400-016

Ellipse(SurgiMend-e) 10 cm x 25 cm 250

- - - - 606-300-022 606-400-018

- - - - 606-304-002 (f) 606-404-001 (f)

PRODUCT ORDER CODES4.0

3.0

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2.0

1.0

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Integra collaborates with the scientific community on: • Regional and National Surgeon Trainings

• Multidisciplinary International Symposia

• Centers of Excellence

We understand the unique needs of the healthcare community and offer clinical education to surgeons all around the world. Integra is committed to connecting our customers to recognized surgeons and thought-leaders to advance professional development and patient care.

INTEGR A REIMBURSEMENT HOTLINE SERVICES

For assistance with the following:• Insurance benefits verification

• Prior authorizations

• Predeterminations

• Claims review

• Navigating the approval process

Phone: 1-877-444-1122, option 3Fax: 1-888-807-0571Email: [email protected]: integralife.com

Disclaimer: Integra intends to use reasonable efforts to provide accurate coding advice, but this advice should not be construed as providing clinical advice, dictating reimbursement policy or substituting for the judgment of a practitioner. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Provider is responsible for verifying coverage with the patient’s insurance carrier. Integra LifeSciences Corporation assumes no responsibility for the timeliness, accuracy and completeness of the information contained herein. Since reimbursement laws, regulations and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists and/or legal counsel regarding coverage, coding and payment issues.

CLINICAL TRAINING IS AT THE HEART OF INTEGRA’S CULTURE

Integra hosted cadaveric labs for education and training

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USA 877-444-1122 n 866-800-7742 faxInternational +1 617-268-1616 n +1 617-268-3282 faxSurgiMend.com

United States, Canada, Asia, Pacific, Latin America

For more information or to place an order, please contact:

SurgiMend, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. All other trademarks and trade names are the property of their respective owners. ©2019 Integra LifeSciences Corporation. All rights reserved. 1226097-1-EN

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.n Warning: Applicable laws restrict these products to sale by or on the order of a physician.n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.